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异体多能干细胞产品商业化规模生产的挑战与解决方案

Challenges and Solutions for Commercial Scale Manufacturing of Allogeneic Pluripotent Stem Cell Products.

作者信息

Lee Brian, Borys Breanna S, Kallos Michael S, Rodrigues Carlos A V, Silva Teresa P, Cabral Joaquim M S

机构信息

PBS Biotech, Inc., Camarillo, CA 93012, USA.

Department of Chemical and Petroleum Engineering, Schulich School of Engineering, University of Calgary, 2500 University Dr. NW, Calgary, AB T2N 1N4, Canada.

出版信息

Bioengineering (Basel). 2020 Mar 28;7(2):31. doi: 10.3390/bioengineering7020031.

DOI:10.3390/bioengineering7020031
PMID:32231012
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7355837/
Abstract

Allogeneic cell therapy products, such as therapeutic cells derived from pluripotent stem cells (PSCs), have amazing potential to treat a wide variety of diseases and vast numbers of patients globally. However, there are various challenges related to the manufacturing of PSCs in large enough quantities to meet commercial needs. This manuscript addresses the challenges for the process development of PSCs production in a bioreactor, and also presents a scalable bioreactor technology that can be a possible solution to remove the bottleneck for the large-scale manufacturing of high-quality therapeutic cells derived from PSCs.

摘要

同种异体细胞治疗产品，如源自多能干细胞（PSC）的治疗性细胞，在全球范围内治疗多种疾病和大量患者方面具有巨大潜力。然而，要生产出足够数量的PSC以满足商业需求，存在各种制造方面的挑战。本手稿阐述了在生物反应器中进行PSC生产工艺开发所面临的挑战，并介绍了一种可扩展的生物反应器技术，该技术可能是消除PSC衍生的高质量治疗性细胞大规模制造瓶颈的一种解决方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1acf/7355837/34c3809d78d4/bioengineering-07-00031-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1acf/7355837/7209552db709/bioengineering-07-00031-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1acf/7355837/bb2e6c9bc03d/bioengineering-07-00031-g002a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1acf/7355837/b4cac4183792/bioengineering-07-00031-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1acf/7355837/a9e39ddef761/bioengineering-07-00031-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1acf/7355837/34c3809d78d4/bioengineering-07-00031-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1acf/7355837/7209552db709/bioengineering-07-00031-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1acf/7355837/bb2e6c9bc03d/bioengineering-07-00031-g002a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1acf/7355837/b4cac4183792/bioengineering-07-00031-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1acf/7355837/a9e39ddef761/bioengineering-07-00031-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1acf/7355837/34c3809d78d4/bioengineering-07-00031-g005.jpg

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